MAUDE Adverse Event Report: MAQUET SAS LUCEA 40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARDLCA309009A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, cover was broken with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as particles falling off may lead to potential infection of the patient.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated, cover was broken with missing particles.There was no injury reported, however, we decided to report the issue in an abundance of caution as particles falling off may lead to potential infection of the patient.According to the information provided by the service unit, the device has been repaired by the replacement of faulty parts - handle interface with fork - lucea 40 ((b)(4)) and transparent plastic cover - lucea 40 ((b)(4)).Based on the information collected, it was established that when the event occurred, the examination light did not meet its specification, since cracks in covers, resulting in missing plastic particles could be considered as technical deficiency, and in this way the device contributed to the event.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to the analysis performed by the subject matter expert, the probable causes of the breakage are the incompatibility of the cleaning products or abnormal use.Maquet sas recommends visual inspection before use according to the user manual (ifu 01701 rev.11, page 21).A daily inspection performed by the user (chipped paint, impact marks and any other damage) will help preventing such event.Maquet sas recommends to inform the customers about the hazards in cases of non-compliance of these instructions.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: LUCEA 40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 15162080
• MDR Text Key: 304966520
• Report Number: 9710055-2022-00314
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 3700712415938
• UDI-Public: (01)3700712415938
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA309009A
• Device Catalogue Number: ARDLCA309009A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1